Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer

NCT05673811 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: P-VCNA-003
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 17

Brief Summary

A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer

Conditions

Pancreatic Adenocarcinoma; Metastatic

Keywords

Cancer; Pancreatic adenocarcinoma; metastatic; oncolytic virus; VCN-01; Gemcitabine; Nab-Paclitaxel

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time from randomization until death in both arms

  From randomization until death for any cause up to 3 years

• Incidence of Adverse Events after VCN-01 IV administration

  Safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm 2 measured as incidence of Adverse Events as assessed by CTCAE v5.0

  From randomization until disease progression assessed up to 3 years

Secondary Outcomes (7)

• Time to progression (TTP) or Progression Free Survival (PFS)

  TTP: From randomization until disease progression assessed up to 3 years or death due to progression.PFS: From randomization to either progression or death from any cause.

• Overall Response Rate (ORR)

  From randomization until death for any cause up to 3 years

• Disease Control Rate (DCR)

  From randomization until death for any cause up to 3 years

• Landmark 1-year survival

  From randomization to 1-year landmark

• Progression Free Survival (PFS) at the 1-year landmark

  From randomization to1-year landmark

Other Outcomes (8)

• Neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs)

  From pre-dose up to 3 years

• PH20 levels in serum

  From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.

• VCN-01 genomes levels in blood

  From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.

Study Arms (2)

Arm 1-SoC

ACTIVE COMPARATOR

Nab-paclitaxel and gemcitabine as SoC.

Drug: Nab-paclitaxel; Drug: Gemcitabine

Arm 2 -VCN-01 + SoC

EXPERIMENTAL

A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.

Drug: Nab-paclitaxel; Drug: Gemcitabine; Genetic: VCN-01

Interventions

Nab-paclitaxel DRUG

Nab-paclitaxel administered as an IV infusion at a rate of 125 mg/m2. Nab-paclitaxel is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.

Arm 1-SoC; Arm 2 -VCN-01 + SoC

Gemcitabine DRUG

Gemcitabine administered as an IV infusion at a dose of 1,000 mg/m2 immediately after the completion of nab-paclitaxel administration as part of SoC. Gemcitabine is administered on Day 1, Day 8 and Day 15 of each 28-day cycles.

Arm 1-SoC; Arm 2 -VCN-01 + SoC

VCN-01 GENETIC

VCN-01 administrated as a single IV infusion at dose 1xE13 viral particles (vp) on Day 1 of the 1st cycle and then again on Day 1 of the 4th cycle (Day 92). On cycle 1 and cycle 4, nab-paclitaxel and gemcitabine administered on Day 8, Day 15 and Day 22.

Arm 2 -VCN-01 + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-specific procedures or assessments.
• Male/female patients aged 18 years or over.
• Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1.
• Patients willing to comply with the study treatment.
• Patients with a minimum life expectancy of 5 months.
• ECOG performance status of 0 or 1.
• Use of a reliable method of contraception in fertile men and women. Female patients of childbearing potential (i.e., female patients who are not postmenopausal or surgically sterile) must agree to use effective contraception. Male patients must agree to use effective contraception or be surgically sterile. All male patients must use a male condom.
• Adequate baseline organ function (hematologic, liver, renal and nutritional)verified by laboratory analyses performed within 72 hours prior to dosing\*:
• Hematology:
• Absolute neutrophil count ≥1.5xE9 /L
• Hemoglobin ≥9 g/dL
• Platelets ≥100xE9/L
• Coagulation (\*except in patients on anticoagulants):
• Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN)
• Activated partial thromboplastin time ≤1.2xULN

You may not qualify if:

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• Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
• Active infection or other serious illness or autoimmune disease at the moment of randomization. Active infection includes tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), Hepatitis B Virus (HBV; positive HBV surface antigen \[HBsAg\] result), Hepatitis C Virus (HCV; positive HCV Ribonucleic acid \[RNA\]), or human immunodeficiency virus (positive HIV 1/2 antibodies). HBV carriers (patients positive for HBsAg) or those patients requiring antiviral therapy treatment for HBV virus or HCV are not eligible to participate.
• However, the following patients are eligible to participate in the study:
• o Patients with past or resolved TB are eligible;
• o Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of HBsAg) are eligible. Blood HBV DNA must be obtained and must be negative in these patients prior to treatment;
• o Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment.
• Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspicion of hepatic fibrosis, a FibroScan must be performed; patients with a value ≥9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis.
• Treatment with another investigational agent within five of that treatment's half-lives prior to infusion of study treatment.
• Viral syndrome diagnosed during the 2 weeks before start of study treatment administration.
• Chronic immunosuppressive therapy and/or disease modifying therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum).
• Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years.
• Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids, patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases).
• Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.

Sponsors & Collaborators

• Theriva Biologics SL: lead

Study Sites (17)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

University of California - Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Louisville - Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Martha Morehouse Tower

Columbus, Ohio, 43221, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Duran i Reynals (ICO)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Gregorio Marañon

Madrid, 28009, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital General Univesitario de Valencia

Valencia, 46014, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tara E Seery, MD

  Hoag Memorial Hospital Presbyterian

  PRINCIPAL INVESTIGATOR

• Edward Kim, MD, PhD

  University of California, Davis Cancer Centre

  PRINCIPAL INVESTIGATOR

• Vivek R Sharma, MD, FACP

  University of Louisville, Brown Cancer Center

  PRINCIPAL INVESTIGATOR

• Alana TH Nguyen, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Arjun Mittra, MD

  Martha Morehouse Tower

  PRINCIPAL INVESTIGATOR

• Christopher Nevala-Plagemann, MD

  Hunstman Cancer Institute, University of Utah

  PRINCIPAL INVESTIGATOR

• Alexander Spira, MD, PhD

  Virginia Cancer Specialists

  PRINCIPAL INVESTIGATOR

• Rocío García, MD, PhD

  Hospital Universtario 12 de octubre

  PRINCIPAL INVESTIGATOR

• Teresa Macarulla, Md, PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Andrés Muñoz, MD, PhD

  Hospital Gregorio-Marañon

  PRINCIPAL INVESTIGATOR

• Carmen Guillén-Ponce, MD, PhD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Miriam Lobo, MD, PhD

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Roberto Pazo, MD, PhD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Inmaculada Gallego, MD, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Berta Laquente, MD. PhD

  Hospital Duran i Reynals (ICO)

  PRINCIPAL INVESTIGATOR

• Eva Martinez de Castro, MD, PhD

  Hospital Universitario Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Mireya Cazorla, MD, PhD

  Hospital Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: January 6, 2023
• Study Start: January 10, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); ES (10)